A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
gp160 Vaccine (Immuno-AG)
+ gp160 Vaccine (MicroGeneSys)
Infections transmises par le sang+16
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination. Patients are stratified into three groups. Fifteen patients previously immunized with MicroGeneSys rgp160 antigen in ACTG 137 and not on antiretroviral therapy will receive intradermal injections of Immuno-AG rgp160 IIIB (vero cell expressed) in one arm, followed 1 week later by intradermal injections of MicroGeneSys rgp160 IIIB (baculovirus expressed) in the opposite arm (stratum 1). Forty patients who are not previously immunized with rgp160 will receive intradermal injections of Immuno-AG gp160 IIIB in one arm simultaneously with MicroGeneSys gp160 IIIB in the opposite arm; these patients are either not on antiretroviral therapy (stratum 2) or currently on antiretroviral therapy (stratum 3). All patients return 48 hours after each injection for skin test reading. PER 4/5/95 AMENDMENT: Patients on all strata will re-enroll to receive Immuno-AG rgp160 MN in one arm simultaneously with MicroGeneSys rgp160 IIIB in the opposite arm.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.50 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Concurrent Medication: Allowed in Step 2 (PER 4/5/95 AMENDMENT): Approved antiretroviral drugs. Patients must have: Documented HIV infection. CD4 count >= 400 cells/mm3. NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to insect proteins. Concurrent Medication: Excluded: Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading. Topical steroids. Prior Medication: PER 4/5/95 AMENDMENT - Excluded: Prior immunization with experimental HIV vaccines (strata 2 and 3 only). Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents within 30 days prior to study entry. Antihistamine or anti-inflammatory medications within 72 hours prior to intradermal injections. PREVIOUS VERSION - Excluded within 30 days prior to study entry: Any antiretroviral drugs (other than AZT, ddI, ddC, or d4T for patients in stratum 3). Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents. Excluded within 72 hours prior to intradermal injections: Antihistamine or anti-inflammatory medications.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 4 sites
Santa Clara Valley Med. Ctr.
San Jose, United StatesSan Mateo County AIDS Program
San Mateo, United StatesNY Univ. HIV/AIDS CRS
New York, United States